Lexology September 23, 2024
Hogan Lovells

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program. CMS is finalizing several significant measures, including changes to certain Medicaid Drug Rebate Program (MDRP) requirements with significant implications for manufacturers, and increased transparency requirements between Medicaid managed care plans and pharmacy benefit managers (PBMs) as to prices PBMs pay pharmacies. CMS has stated that the Final Rule is generally effective on November 19, 2024, with the exception of two provisions regarding Medicaid managed care plans (as noted below).

As notable are the many proposals from the May 26, 2023 proposed rule (Proposed Rule) that CMS did not...

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